Website Integrated Resources, Inc
Integrated Resources, Inc
Company : Integrated Resources, Inc
Job Title: Clinical Trial Manager
Job Location: San Francisco, CA
Job Duration: 10-11 Months (possibility of extension)
Payrate: $60 – $80/hr. on w2
Offsite, East Coast preferred, Midwest okay
Job Summary:
- The Clinical Trial Manager will independently manage all components of a high complexity clinical trial, leading a multidisciplinary, cross-functional Study Management Team.
- The Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Client SOPs.
- This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
Duties and Responsibilities:
- Oversee and manage all aspects of a clinical trial in accordance with Client SOPs, ICH/GCP regulations and study-specific manuals and procedures.
- Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable.
- Develop and manage effective relationships with key study stakeholders.
- Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.).
- Lead the identification, evaluation and hiring of appropriate CROs and other third-party study vendors in accordance with Client SOPs.
- Management of CROs and other third-party vendors, including setting expectations, training, managing timelines and deliverables, and issue management.
- Manage the clinical study budget, ensuring the project remains within Product and that out of Product activities are identified and handled appropriately.
- In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary.
- Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents.
- Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock.
- Project and coordinate study supply and packaging requirements.
- Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions.
- Provide weekly enrollment and program updates to senior management.
- Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations.
- Lead or participate in functional initiatives and/or activities as assigned.
- May mentor and develop junior clinical operations staff.
Education:
- Bachelor’s degree or equivalent is required (life science degree is preferred).
Experience:
- 8-10+ years in the pharmaceutical industry is required, including 4 years overseeing trial management.
- Strong experience working as a Clinical Research Associate is preferred.
- Vendor management experience required.
Knowledge, Skills and Abilities:
- Must have demonstrated problem solving abilities and strong organizational skills.
- Excellent written and verbal communication skills are required.
- Strong computer skills (MS Office) are required.
- Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required.
- Must be a demonstrated self-starter and team player with strong interpersonal skills.
- Must possess excellent cross-functional clinical project management skills.
- Demonstrated ability to develop and implement SOPs and Study Plans.
- Some travel required.
City: San Francisco
Start Date: 02/16/2026
End Date: 12/31/2026
Schedule Hours Per Week: 40.00
Schedule Hours Per Day: 8.00
Schedule Days Per Week: 5.00
